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FDA PMA

Nucleic Acid Based Assay, Microsatellite Instability

PMA Number: P250005 · 2025-08-15

ApplicantBiocartis Us, Inc.
Decision Date2025-08-15
PMA NumberP250005
Product CodeSFL
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeMG

Device Summary

Nucleic Acid Based Assay, Microsatellite Instability is the device name listed in this FDA 510(k) record. The listed applicant is Biocartis Us, Inc.. It received FDA 510(k) clearance on 2025-08-15. The device is classified under product code SFL. It was reviewed by the MG advisory panel.

Frequently Asked Questions

What is the Nucleic Acid Based Assay, Microsatellite Instability?

Nucleic Acid Based Assay, Microsatellite Instability is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Biocartis Us, Inc..

When did Nucleic Acid Based Assay, Microsatellite Instability receive FDA 510(k) clearance?

The clearance date for Nucleic Acid Based Assay, Microsatellite Instability can be found in the official FDA records.

Who is the listed applicant for Nucleic Acid Based Assay, Microsatellite Instability?

The FDA 510(k) record lists Biocartis Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nucleic Acid Based Assay, Microsatellite Instability?

The FDA product code for Nucleic Acid Based Assay, Microsatellite Instability is SFL.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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